Chances for Success of CavatermTM Surgery as a Function of Uterus Probe Length

NCT ID: NCT01436903

Last Updated: 2013-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-04-30

Brief Summary

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CavatermTM is a second-generation thermal balloon ablation device in the management of menorrhagia. The purpose of this study is to investigate the success (questionnaire) of CavatermTM dependent on uterus probe length, especially corpus probe length, which is measured during surgery.

Detailed Description

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Conditions

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Menorrhagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Thermal Balloon Endometrial Ablation

Thermal Balloon Endometrial Ablation for 10 minutes after curettage

Intervention Type DEVICE

Other Intervention Names

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CavatermTM

Eligibility Criteria

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Inclusion Criteria

* CavatermTM operation because of menorrhagia
* timeframe: January 2006 till August 2009
* older than 29 years and younger than 56 years

Exclusion Criteria

* pregnancy
* fragmentary filled questionnaire
* more than 1 CavatermTM operation
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Beda Hartmann

Univ.-Doz. Dr. Mag.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beda W. Hartmann, Univ.-Doz.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Landesklinikum Thermenregion Neunkirchen

Neunkirchen, Lower Austria, Austria

Site Status

Countries

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Austria

Other Identifiers

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743/2010

Identifier Type: -

Identifier Source: org_study_id

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